Recruiting
Phase 3

GSK5784283

Sponsor:

GlaxoSmithKline

Code:

NCT07782970

Conditions

Nasal Polyps

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

GSK5784283

Placebo

Standard of Care

Study Details

Brief summary:

The aim of this study is to assess the efficacy and safety of GSK5784283 administered as add-on maintenance therapy to participants with CRSwNP.

Conditions

Nasal Polyps

Study ID

NCT07782970

Start date

Sep 28, 2026

Status verified date

Oct, 2026

Completion date

Oct 30, 2029

Anticipated

Primary completion date

Mar 6, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 18 years of age and older
  • Male or eligible female participants
  • Physician-diagnosed CRSwNP for greater than or equals to (>=) 12 months before screening.
  • Have had at least one of the following at Visit 1:

  • Any documented history of Nasal surgery for the removal of NP (or contraindications/intolerance to Nasal surgery)
  • Have used at least 3 consecutive days of Systemic corticosteroid (SCS) or 1 intramuscular depot injectable dose (or contraindications/intolerance to SCS) in the previous 12 months (but not in the past 3 months before screening) for the treatment of NP.
  • Endoscopic bilateral NP score consistent with severe CRSwNP assessed by the investigator.
  • Symptoms of Chronic rhinosinusitis (CRS)

  • Presence of symptoms of CRS for at least 12 weeks prior to Visit 1 such as rhinorrhea and/or reduction or loss of smell and
  • Moderate to severe nasal congestion/blockade/obstruction at Visit 1 based on clinical assessment by the investigator.
  • Participants must have an elevated SNOT-22 score at screening.
  • Participants must be on daily treatment with intranasal corticosteroids (INCS) (including intranasal liquid steroid wash/douching) for at least the 8 weeks prior to screening.

Exclusion Criteria:

  • As a result of medical interview, physical examination, or screening investigation the physician responsible considers the participant unfit for the study.
  • Have the following conditions:- Cystic fibrosis, Antrochoanal polyps, Nasal cavity tumor (malignant or benign), Fungal rhinosinusitis, Rhinitis medicamentosa, Hyper-eosinophilic syndrome (HES) Eosinophilic granulomatosis with polyangiitis (EGPA) or Churg-Strauss Syndrome or eosinophilic esophagitis, Helminth parasitic infection in the past 6 months unless treated and have responded to therapy.
  • Female who are pregnant
  • Known substance or alcohol abuse
  • Current smokers (including e-cigarettes) or ex-smokers of 6 months or less
  • Other significant medical conditions (eg immunogenicity, Human immunodeficiency virus \[HIV\], viral hepatitis, tuberculosis \[TB\], cardiac and liver disease) that could impact participants' safety or study outcomes.
  • Where nasal surgery is contraindicated
  • Nasal surgery in the past 6 months
  • Asthma exacerbation in the past 4 weeks.

Study Design

Enrollment

218 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Participants receiving GSK5784283 + standard of care (SoC)

placebo comparator: Participants receiving Placebo + SoC

Interventions

GSK5784283

GSK5784283 will be administered.

Placebo

Placebo will be administered.

Standard of Care

Standard of Care will be administered.

Primary outcome measure

  • Change from Baseline in total endoscopic nasal polyps (NP) score at Week 52 [ Time Frame: Baseline and Week 52 ]
  • Change from Baseline in mean nasal obstruction score using Verbal Response Scale (VRS) from Week 51 through to Week 52 [ Time Frame: Baseline, Weeks 51 to 52 (time - average) ]

Central Contacts and Locations

Central contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

+44 (0) 20 89904466GSKClinicalSupportHD@gsk.com

Locations

GSK Investigational Site

Recruiting

Los Angeles, California, United States, 90006

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Kevin Choi

GSK Investigational Site

Recruiting

Tulsa, Oklahoma, United States, 74137

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Scott Cordray

More Information

Sponsor

GlaxoSmithKline

Last update posted

Oct 14, 2026

Last verified

Oct, 2026

Keywords

  • Chronic rhinosinusitis
  • Chronic rhinosinusitis with nasal polyps
  • GSK5784283
  • Felcorekibart
  • Nasal polyps
  • Standard of care
  • Sinus disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-15. This information was provided to ClinicalTrials.gov by GlaxoSmithKline on 2026-10-14. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.